Latest news with #TEVIMBRA
Business Wire
10-07-2025
- Health
- Business Wire
European Commission Approves TEVIMBRA ® in Combination with Chemotherapy as a First-Line Treatment for Nasopharyngeal Carcinoma
SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved TEVIMBRA ® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. Nasopharyngeal carcinoma is a rare cancer in which malignant cells form in the nasopharynx, the upper part of the throat located behind the nose. 1 'The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease,' said Prof. Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. 'Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care.' The approval in NPC is based on results of RATIONALE-309 (NCT03924986), a double-blind, placebo-controlled, multicenter, Phase 3 study, which randomized 263 treatment-naïve patients who received either TEVIMBRA in combination with gemcitabine plus cisplatin or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001), showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm. An updated analysis with an additional 12 months of follow-up showed efficacy results consistent with the interim analysis. Clinically meaningful and sustained improvement in overall survival (OS) was observed, with a median OS of 45.3 months for TEVIMBRA plus chemotherapy compared to 31.8 months for placebo plus chemotherapy. TEVIMBRA plus chemotherapy was generally well tolerated, and no new safety signals were identified. Pooled safety data included over 3,900 patients who received TEVIMBRA, either as monotherapy (n=1,952) or in combination with chemotherapy (n=1,950), at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 10%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and thrombocytopenia. 'Following our recent EU approval of TEVIMBRA for extensive-stage small cell lung cancer, this new authorization in nasopharyngeal carcinoma reflects strong momentum in broadening access to our immunotherapy across solid tumors,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.' TEVIMBRA was previously approved in the EU as a first-line treatment for eligible patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings. About Nasopharyngeal Cancer (NPC) Nasopharyngeal cancer, also known as nasopharyngeal carcinoma, is a type of head and neck cancer that starts in the nasopharynx, the upper throat passage that connects the nose to the lungs. 2 NPC, which can be categorized into different pathological subtypes (keratinizing squamous, non-keratinizing, and basaloid squamous) 3, is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging. 4 In 2020, NPC accounted for approximately 133,000 new cancer cases and 80,000 deaths per year globally and exhibits a unique geographical pattern, with its prevalence notably concentrated in Asia. 5 While the overall 5-year survival rate for NPC is approximately 63%, in advanced disease the survival rate decreases to 49%. 6 About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally. Important Safety Information The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency. This information is intended for a global audience. Product availability and approved indications vary by country. Please refer to local prescribing information for complete details. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA plus chemotherapy to significantly reduce the risk of disease progression or death for patients with recurrent or metastatic NPC; BeOne's ability to expand patient access to cancer treatments; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom. 1 National Cancer Institute at the National Institutes of Health. Nasopharyngeal Cancer Treatment (PDQ®)–Patient Version. 2 Cleveland Clinic. Nasopharynx. 3 American Cancer Society. What Is Nasopharyngeal Cancer? 4 Wei, X., et al. (2024) Nasopharyngeal cancer risk assessment by country or region worldwide from 1990 to 2019. BMC Public Health, 24, 1931. 5 Yang, Y., et al. (2023) Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell, 41(7): 1061–1072. 6 American Cancer Society. Survival Rates for Nasopharyngeal Cancer.
Business Standard
24-06-2025
- Business
- Business Standard
Glenmark Pharma launches TEVIMBRA in India
Glenmark Pharmaceuticals announced that it had launched TEVIMBRA (tislelizumab) in India after receiving approval from the Central Drugs Standard Control Organization (CDSCO). The drug is a specially designed anti-PD-1 monoclonal antibody created by BeiGene, now BeOne Medicines, which focuses on oncology. TEVIMBRA is intended for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) when combined with chemotherapy. It is also approved for second-line treatment of locally advanced or metastatic NSCLC and esophageal squamous cell carcinoma (ESCC) as a standalone therapy. The launch signifies Glenmark's entry into the immuno-oncology market in India. This strategic step aims to expand its innovative oncology offerings. NSCLC represents more than 80% of lung cancer cases, while ESCC is the most common type of esophageal cancer in India. TEVIMBRA is already approved and available in major markets such as the US, the EU, Australia, and China. The therapy specifically targets PD-1 receptors, helping to restore T-cell function while reducing off-target immune suppression. It has shown strong effectiveness and a good safety profile in several key Phase 3 trials across a variety of solid tumors. Alok Malik, President and Business Head India Formulations, Glenmark Pharmaceuticals, said, At a time when the cancer burden is rising sharply, we are proud to enable oncologists and patients to access TEVIMBRA, a therapy with proven efficacy and safety outcomes, strong science, and meaningful impact. Immuno-oncology offers a promising future for the treatment of various types of advanced cancers that are difficult to treat. Our foray in this area marks a significant inflection point in our journey to build a world-class oncology portfolio that is innovative, inclusive and at the same time life-changing for patients. Glenmark Pharmaceuticals is a research-led, global pharmaceutical company, having a presence across branded, generic, and OTC segments, with a focus on therapeutic areas of respiratory, dermatology and oncology. On a consolidated basis, Glenmark Pharmaceuticals reported a net profit of Rs 4.65 crore in Q4 March 2025 as against a net loss of Rs 1,218.28 crore in Q4 March 2024. Net sales rose 6.77% year-on-year to Rs 3220.13 crore in Q4 March 2025. Shares of Glenmark Pharmaceuticals rose 0.78% to Rs 1,699.25 on the BSE.
Business Standard
24-06-2025
- Health
- Business Standard
Glenmark Pharmaceuticals launches TEVIMBRA in India
Glenmark Pharmaceuticals (Glenmark) launched TEVIMBRA (tislelizumab) in India following the approval by Central Drugs Standard Control Organization (CDSCO). TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. It is indicated for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy and second-line treatment of locally advanced or metastatic NSCLC and esophageal squamous cell carcinoma (ESCC) as monotherapy. This launch marks Glenmark's first foray into immune-oncology in India and is a major milestone in expanding its innovative oncology portfolio. NSCLC is the most common type of lung cancer, representing over 80% of all lung cancer cases. Similarly, ESCC is the most common histological subtype of esophageal cancer in India. TEVIMBRA caters to the needs of this significant patient population by offering a differentiated and proven treatment option for these cancers. TEVIMBRA is approved and marketed in multiple leading global markets including the United States, European Union, Australia and China. Designed to selectively bind to PD-1 receptors, TEVIMBRA restores T-cell function while minimizing off-target immune suppression and has demonstrated robust efficacy with a favorable safety profile across diverse solid tumor types in multiple pivotal Phase 3 studies and through a comprehensive global clinical development program.
Business Upturn
24-06-2025
- Business
- Business Upturn
Glenmark Pharmaceuticals launches TEVIMBRA in India for advanced lung and esophageal cancer treatment
By Aditya Bhagchandani Published on June 24, 2025, 09:50 IST Glenmark Pharmaceuticals has announced the launch of TEVIMBRA® (tislelizumab) in India, marking its entry into the immuno-oncology space. This anti-PD-1 monoclonal antibody, developed by global oncology firm BeiGene (now BeOne Medicines), is approved for the treatment of advanced non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma (ESCC). The drug is designed to restore T-cell function and minimize off-target immune suppression, having shown strong efficacy and safety in global trials. Already approved in over 46 countries including the U.S. and EU, TEVIMBRA has been used in treating more than 1.5 million patients worldwide. Glenmark's President Alok Malik stated that the company is committed to transforming cancer care in India by making cutting-edge immunotherapies accessible. The launch comes at a time when cancer incidence in India is sharply rising, especially NSCLC and ESCC which dominate their respective cancer types in the country. This milestone aligns with Glenmark's broader ambition to build a globally benchmarked oncology portfolio, adding to its existing focus areas of respiratory and dermatology. Disclaimer: This content is for informational purposes only and not a substitute for professional medical advice. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Business Upturn
28-05-2025
- Business
- Business Upturn
BeOne Medicines Launches Following Redomiciliation to Switzerland, Marking a New Chapter in Global Oncology
Basel, Switzerland & San Carlos, Calif., United States: BeOne well-positioned to deliver transformative treatments to patients worldwide with powerful oncology portfolio, pioneering clinical development approach, and expanded global manufacturing and commercial capabilities Redomiciliation to Switzerland bolsters Company's presence in leading global biopharmaceutical hub, marks next step in becoming a diversified biotechnology company focused on oncology BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., today announced its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company's evolution. This press release features multimedia. View the full release here: BeOne Medicines' biologics manufacturing facility and clinical R&D center in Hopewell, NJ. 'BeOne represents more than a name change—it's not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what's possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer,' said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. 'While I know that our work is not done, I am extremely proud of the progress we have made with the explosive growth of BRUKINSA as the backbone of our hematology franchise, the expansion of our PD-1 inhibitor, TEVIMBRA, and our potentially transformative oncology pipeline of more than 50 investigational assets, one of the most prolific in the industry. After 15 years of relentless innovation and strategic investment to boost our internal global capabilities, we are just getting started, and I look forward to working together as BeOne.' The new name and redomiciliation to Switzerland from the Cayman Islands were approved by shareholders on April 28. The transition to the BeOne name across the Company's worldwide operations on six continents will happen in phases. The redomiciliation to Switzerland strengthens BeOne's presence and deepens its roots in a global biopharmaceutical hub, further enabling its growth strategy of bringing innovative medicines to patients around the world. Industry-Leading Innovation and Global Scale BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development, and manufacturing capabilities. This unique model harnesses time and cost efficiencies to improve patient access, enables close oversight to enforce high standards across R&D and manufacturing, and safeguards our operational resilience for long-term growth. BRUKINSA has the broadest label in its treatment class and leads in new patient starts across all of its approved indications in the U.S. It also is the cornerstone of BeOne's hematology franchise as a foundational treatment alongside late-stage BCL2 inhibitor sonrotoclax and potential first-in-class BTK protein degrader, BGB-16673, which was developed from the Company's proprietary CDAC platform. BeOne also is focused on building future solid tumor franchises in breast, lung, and gastrointestinal cancers. By leveraging its platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates, the Company is positioned to transform the future of oncology treatment. BeOne's entrepreneurial research team, comprising more than 1,100 colleagues, advanced 13 new molecular entities into the clinic in 2024 alone, outpacing even the largest pharmaceutical companies. Further, its nearly 3,700-strong clinical development team has active or planned trials across more than 45 countries and regions, accelerating early-stage innovation through its 'Fast to Proof-of-Concept' approach. To date, the Company has enrolled more than 25,000 patients in more than 170 trials, delivering speed and cost advantages that set it apart from industry peers. In addition, BeOne continues to expand its global manufacturing network with its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. This state-of-the-art site enables scalable production capacity to support the Company's rapidly growing pipeline, operational resilience, and global ambitions. About BeOne BeOne Medicines, formerly known as BeiGene, is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne's ability to deliver transformative treatments to patients worldwide; the potential and future success of BeOne's oncology pipeline; BeOne's presence in Switzerland and its ability to enable further growth; the sustainable advantage of BeOne's strategic investments and its ability to improve patient access; the future long-term growth of the Company; BeOne's ability to transform the future of oncology treatment; and BeOne's plans, commitments, aspirations and goals under the caption 'About BeOne'. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom . View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
